Clinical trial · Interventional
ROGYcare: The Impact of a Cancer Survivorship Care Plan on Patient Reported Outcomes and Health Care Providers
ROGYcare: The Impact of a Cancer Survivorship Care Plan on Patient Reported Outcomes and Health Care Providers. A Pragmatic Cluster Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Earlier diagnoses and improved treatments have contributed to the growing cohort of cancer survivors. Nevertheless, these patients remain at risk for adverse long-term or late physical or psychosocial effects of cancer and its treatment. There is increasing recognition to improve information disclosure and cancer survivorship care. The American Institute of Medicine (IOM) and Health Council of the Netherlands both recommend that cancer survivors receive a summary of their course of treatment as a formal document, that also includes recommendations for subsequent cancer surveillance, management of late effects, and strategies for health promotion, the Survivorship Care Plan (SCP). However, no evidence exists concerning the positive and negative effects of the implementation of the SCP in daily clinical practice. The purpose of this study is to assess the impact of SCP care in routine clinical practice on cancer survivors' satisfaction with information disclosure and care, quality of life, illness perception, and health care use.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrium Cancer | — | UNRESOLVED | — |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SCP care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Usual care
- description
- The gynaecological oncologist (GO) provides care as usual. Currently, hospitals provide follow-up following the Dutch guidelines, meaning that they see their patients on given time points based on the number of years after diagnosis. Most hospitals give their patients leaflets regarding the diagnosis and treatment they receive, however none of them provide personalized information. All information is given during the initial treatment phase, but none of the GOs give additional information during follow-up. None of the GOs is actively screening on psychosocial needs. As this might change in time, we will ask the providers and patients about the type of information they provide, respectively, receive.
- type
- EXPERIMENTAL
- label
- SCP care
- description
- After initial treatment, the GO provides the patient with a paper SCP and takes time to discuss all items in the SCP. Each time during follow-up meetings between patient and GO, the patient will receive an updated SCP if applicable. The paper SCP is extracted from the online registration system 'ROGY' (Registrationsystem Oncological GYnaecology) and combines personal patient and disease data with tailored information that is related to the specific situation of this patient. Recurrences, toxicities or additionally involved specialists will be registered in ROGY and automatically updated in the personal SCP.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women who are newly diagnosed with endometrial or ovarian cancer in one of the 12 participating hospitals. * The patients have to be able to complete a Dutch questionnaire. Exclusion Criteria: * Patients who are not able to read or write Dutch will be excluded, as they are not able to complete a Dutch questionnaire.
References
Publications (10)
- BACKGROUNDvan de Poll-Franse LV, Nicolaije KA, Vos MC, Pijnenborg JM, Boll D, Husson O, Ezendam NP, Boss EA, Hermans RH, Engelhart KC, Haartsen JE, Pijlman BM, Feijen HW, Mertens HJ, Nolting WE, van Beek JJ, Roukema JA, Kruitwagen RF. The impact of a cancer Survivorship Care Plan on gynecological cancer patient and health care provider reported outcomes (ROGY Care): study protocol for a pragmatic cluster randomized controlled trial. Trials. 2011 Dec 5;12:256. doi: 10.1186/1745-6215-12-256. PMID 22141750
- RESULTNicolaije KA, Ezendam NP, Vos MC, Pijnenborg JM, Boll D, Boss EA, Hermans RH, Engelhart KC, Haartsen JE, Pijlman BM, van Loon-Baelemans IE, Mertens HJ, Nolting WE, van Beek JJ, Roukema JA, Zijlstra WP, Kruitwagen RF, van de Poll-Franse LV. Impact of an Automatically Generated Cancer Survivorship Care Plan on Patient-Reported Outcomes in Routine Clinical Practice: Longitudinal Outcomes of a Pragmatic, Cluster Randomized Trial. J Clin Oncol. 2015 Nov 1;33(31):3550-9. doi: 10.1200/JCO.2014.60.3399. Epub 2015 Aug 24. PMID 26304900
- RESULTEzendam NP, Nicolaije KA, Kruitwagen RF, Pijnenborg JM, Vos MC, Boll D, van Bommel M, van de Poll-Franse LV. Survivorship Care Plans to inform the primary care physician: results from the ROGY care pragmatic cluster randomized controlled trial. J Cancer Surviv. 2014 Dec;8(4):595-602. doi: 10.1007/s11764-014-0368-0. Epub 2014 May 28. PMID 24866923
- RESULTNicolaije KA, Ezendam NP, Vos MC, Pijnenborg JM, van de Poll-Franse LV, Kruitwagen RF. Oncology providers' evaluation of the use of an automatically generated cancer survivorship care plan: longitudinal results from the ROGY Care trial. J Cancer Surviv. 2014 Jun;8(2):248-59. doi: 10.1007/s11764-013-0327-1. Epub 2013 Dec 20. PMID 24357226
- RESULTNicolaije KA, Ezendam NP, Pijnenborg JM, Boll D, Vos MC, Kruitwagen RF, van de Poll-Franse LV. Paper-Based Survivorship Care Plans May be Less Helpful for Cancer Patients Who Search for Disease-Related Information on the Internet: Results of the Registrationsystem Oncological Gynecology (ROGY) Care Randomized Trial. J Med Internet Res. 2016 Jul 8;18(7):e162. doi: 10.2196/jmir.4914.